INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
PARAMED SYRUP

SCHEDULING STATUS:
Not-scheduled

PROPRIETARY NAME
(and dosage form):

PARAMED SYRUP

COMPOSITION:
Each 5 mL syrup contains:
        Paracetamol        120 mg
Preserved with
        Sodium Methyl Hydroxybenzoate        0,115% m/v
        and Sodium Propyl Hydroxybenzoate        0,056% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 - Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic actions.

INDICATIONS:
For the relief of mild to moderate pain and fever such as headache, toothache and pain and fever associated with colds and flu.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol and other ingredients in the medicine.

WARNINGS:
1.        Dosages in excess of those recommended may cause severe liver damage.
2.        Do not use continuously for more than 10 days without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE:
CHILDREN:
        9 - 10 years        10 - 20 mL
        5 - 8 years        5 to 10 mL
        1 - 4 years        2,5 to 5 mL
        Infants 3 months - 1 year        2,5 mL
Repeat dosage every 4 to 6 hours if necessary but not more than 4 doses in 24 hours.

Do not use continuously for more than 10 days without consulting your doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.
1.        Consult your doctor if no relief is obtained with the recommended dosage.
2.        Patients suffering from liver or kidney disease should take paracetamol under medical supervision.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Liver damage which may be fatal may appear only after a few days. Symptoms of overdosage include nausea and vomiting. Acute intoxication causes kidney failure.
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.

The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
A clear dark red liquid with a cherry flavour and odour.

PRESENTATION:
Bottles of 100 mL syrup.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C)
Keep out of reach of children.

REGISTRATION NUMBER:
W/5.8/47

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Group Laboratories SA (Pty) Ltd.
21 Wrench Road,
Isando
Transvaal

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1989
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